Libtayo (cemiplimab-rwlc) Injection recall
FDA recall D-0767-2026 · initiated Jul 28, 2026
Regeneron Pharmaceuticals Inc recalled Libtayo (cemiplimab-rwlc) Injection in Jul 2026 — an FDA Class II recall (D-0767-2026) because Lack of Assurance of Sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 21,353 vials
Details
- Product
- Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
- Recalling company
- Regeneron Pharmaceuticals
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jul 28, 2026
- FDA report date
- Aug 26, 2026
Frequently asked
- Was Libtayo (cemiplimab-rwlc) Injection recalled?
- Regeneron Pharmaceuticals Inc recalled Libtayo (cemiplimab-rwlc) Injection in Jul 2026 — an FDA Class II recall (D-0767-2026) because Lack of Assurance of Sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Libtayo (cemiplimab-rwlc) Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0767-2026 was: Lack of Assurance of Sterility
- Is a recalled Libtayo (cemiplimab-rwlc) Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Libtayo (cemiplimab-rwlc) Injection are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot: 8494000002, Exp 7/31/28. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0767-2026.